THE WOODLANDS, Texas,
March 30, 2016 /PRNewswire/
-- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) today
announced that it has submitted a New Drug Application to the U.S.
Food and Drug Administration seeking approval for the marketing and
sale of telotristat etiprate, an oral drug for the treatment of
carcinoid syndrome. The FDA has a 60-day filing review period
to determine whether the NDA is complete and acceptable for
filing. Lexicon has requested a Priority Review by the FDA as
part of the NDA filing.
"The filing of the NDA for telotristat etiprate brings us one
step closer to the possibility of bringing this innovative new
investigational treatment to the market to improve the lives of the
community of patients and caregivers who live with carcinoid
syndrome on a daily basis," said Lexicon President and Chief
Executive Officer, Lonnel Coats. "We
look forward to working closely with the FDA during the review
process."
The NDA filing is supported by the results from TELESTAR, a
pivotal Phase 3 clinical trial of telotristat etiprate in patients
with carcinoid syndrome, and TELECAST, a Phase 3 companion study to
TELESTAR. Results from TELESTAR demonstrated a statistically
significant reduction from baseline compared to placebo in the
average number of daily bowel movements over the 12-week study
period (p<0.001), meeting the study's primary
endpoint. Top-line results from TELECAST demonstrated a
statistically significant reduction in urinary
5-hydroxyindoleacetic acid (5-HIAA, the main metabolite of
serotonin) at week 12 (p<0.001) as compared to placebo, meeting
that study's primary endpoint. The proportions of patients
with treatment-emergent adverse events, serious adverse events and
discontinuation due to adverse events were generally similar
between the telotristat etiprate and placebo arms in both
studies.
Carcinoid syndrome is a rare disease affecting thousands of
cancer patients with metastatic neuroendocrine tumors (mNETs) that
have spread to the liver and other organs from the gastrointestinal
tract. The condition is characterized by frequent and
debilitating diarrhea that often prevents patients from leading
active, predictable lives, as well as facial flushing, abdominal
pain, fatigue and, over time, heart valve damage.
About Telotristat Etiprate
Discovered using Lexicon's unique approach to gene science,
telotristat etiprate is the first investigational drug in clinical
studies to target tryptophan hydroxylase, an enzyme that triggers
the excess serotonin production within mNET cells that leads to
carcinoid syndrome. While existing treatments for carcinoid
syndrome work to reduce the release of serotonin outside tumor
cells, telotristat etiprate works at the source to reduce serotonin
production within the tumor cells. By specifically inhibiting
serotonin production, telotristat etiprate seeks to control this
important driver of carcinoid syndrome and, in turn, provide
patients with more control over their disease.
Telotristat etiprate has received Fast Track and Orphan Drug
designation from the U.S. Food and Drug Administration.
Lexicon retains rights to market telotristat etiprate in the
U.S. and Japan, and is building
the in-house commercial infrastructure to serve the U.S. market.
Lexicon has a license and collaboration agreement with Ipsen to
commercialize telotristat etiprate in Europe and other countries outside the U.S.
and Japan.
About Lexicon
Lexicon is a fully integrated biopharmaceutical company that is
applying a unique approach to gene science based on Nobel
Prize-winning technology to discover and develop precise medicines
for patients with serious, chronic conditions. Through its
Genome5000™ program, Lexicon scientists have studied the role and
function of nearly 5,000 genes over the last 20 years and have
identified more than 100 protein targets with significant
therapeutic potential in a range of diseases. Through the precise
targeting of these proteins, Lexicon is pioneering the discovery
and development of innovative medicines to safely and effectively
treat disease. Lexicon has a pipeline of promising drug candidates
in clinical and pre-clinical development in oncology, diabetes and
metabolism. For additional information please visit
www.lexpharma.com.
Safe Harbor Statement
This press release contains "forward-looking statements,"
including statements relating to Lexicon's clinical development of
telotristat etiprate (LX1032) and the results of and projected
timing of clinical trials and the potential therapeutic and
commercial potential of telotristat etiprate. In addition, this
press release also contains forward-looking statements relating to
Lexicon's growth and future operating results, discovery and
development of products, strategic alliances and intellectual
property, as well as other matters that are not historical facts or
information. All forward-looking statements are based on
management's current assumptions and expectations and involve
risks, uncertainties and other important factors, specifically
including the risk that clinical studies of telotristat etiprate
may be halted, delayed or otherwise not demonstrate safety or
efficacy, the risk that Lexicon and its licensees may be unable to
file for regulatory approval of telotristat etiprate with the FDA
and other regulatory authorities in accordance with its currently
anticipated timelines, the risk that the FDA and other regulatory
authorities may not grant regulatory approval of telotristat
etiprate in accordance with Lexicon's currently anticipated
timelines or at all, and the risk that such regulatory approvals,
if granted, may have significant limitations on the approved use of
telotristat etiprate. As a result, telotristat etiprate may never
be successfully commercialized. Other risks include Lexicon's
ability to meet its capital requirements, successfully conduct
preclinical and clinical development and obtain necessary
regulatory approvals of its other potential drug candidates,
achieve its operational objectives, obtain patent protection for
its discoveries and establish strategic alliances, as well as
additional factors relating to manufacturing, intellectual property
rights, and the therapeutic or commercial value of its drug
candidates. Any of these risks, uncertainties and other factors may
cause Lexicon's actual results to be materially different from any
future results expressed or implied by such forward-looking
statements. Information identifying such important factors is
contained under "Risk Factors" in Lexicon's annual report on Form
10-K for the year ended December 31,
2015, as filed with the Securities and Exchange Commission.
Lexicon undertakes no obligation to update or revise any such
forward-looking statements, whether as a result of new information,
future events or otherwise.
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SOURCE Lexicon Pharmaceuticals, Inc.